New Indications
What Are New Indications?
New indications is a term drug companies use to allude to new evidence connoting that there might be new applications for an existing medication or strategy. This type of information is closely followed by investors, who can access such discoveries through the press releases issued on companies' investor relations pages.
How New Indications Work
New indications are an early sign that a specific medication or system might be worth investing in further. For instance, a company that has proactively gotten [regulatory approval](/managed market) for a specific medication would report new indications assuming their research proposes that extra applications for that medication may be conceivable. New indications are thusly seen as a positive development by most investors since they could connote extra revenue-producing opportunities for a company's existing medications.
In the United States, companies must go through a thorough and extended process to carry new medications to the market. The Food and Drug Administration (FDA) manages the development and endorsement of new medications through their New Drug Application (NDA) process. The cycle regularly requires a long time to complete, with some extending more than a decade. Notwithstanding this extended interaction, just around 30% of new candidates have their NDAs approved.
Significant
Despite the fact that repurposing an existing medication can lead to decreased research and development (R&D) costs, there are by the by major costs engaged with getting last FDA endorsement for such reused drugs. In any case, on the grounds that these medications have previously gone through the FDA's NDA cycle, many companies view them as a safer investment as compared to growing new medications without any preparation.
Consequently, one of the most efficient ways for drug companies to venture into new markets is find new or expanded applications for products that have proactively received FDA endorsement. As a matter of fact, a few companies have some expertise in repurposing previously approved drugs with an end goal to come to the commercialization of new medicines all the more rapidly.
True Example of a New Indication
New indications frequently show up in news releases for medical therapies and drug companies while alluding to medications or equipment included. For instance, on Aug. 16, 2018, the FDA delivered another indication endorsement for the medication Opdivo (nivolumab), which treats malignant growths like advanced melanoma, advanced renal cell carcinoma, and advanced squamous cell carcinoma of the head and neck.
At the point when it was first approved in December 2014, this medication had a more narrow planned utilization, having some expertise in patients with advanced melanoma that couldn't be taken out with a medical procedure or that presently not answered different medications. The new indication in this way addresses an opportunity for the medication to be sold into a bigger addressable market than recently anticipated.
Features
- Repurposing existing medications as such can demonstrate less costly than growing new medications without any preparation.
- New indications alludes to news connoting that an existing medication might have a more extensive scope of medical applications.
- Investors frequently view new indications as a bullish indicator, guessing that the company being referred to will approach new revenue streams for a somewhat minimal price.
